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Peer-reviewedCC BY 4.0Frontiers in Immunology

Ulcerative colitis reporting across medications: FAERS analysis and cross-species transcriptomic triangulation

  • Huan Long1
  • Caihua Duan2
  • Jiusi Liu3
  • Nanxi Xiao2
  • Jiang Huang4
  • Huilei Zeng1
  • Zhenling Gao4
  • Yao Chen1
4 affiliations
  1. 1Department of Emergency, Ji’an Central People’s Hospital, Jizhou District
  2. 2Department of Gastroenterology, Ji’an Central People’s Hospital, Jizhou District
  3. 3Department of Gastrointestinal Surgery, Ji’an Central People’s Hospital, Jizhou District
  4. 4Department of Cardiology, Ji’an Central People’s Hospital, Jizhou District
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Abstract

Background: Ulcerative colitis (UC) is reported with medications from different therapeutic classes. We examined these reporting associations together with recorded clinical context and tested whether experimental cytokine-blockade signatures align with human UC mucosal expression.

Methods: FAERS reports from 2004Q1–2024Q4 were restricted to health professionals and primary-suspect medications. Ten previously identified candidates were evaluated using unique report–generic counts, reporting odds ratios (RORs), proportional reporting ratios, and a supportive Bayesian information component. Sensitivity analysis excluded complete reports recording UC as an indication. Directional signatures from five antibody-versus-isotype contrasts in a 42-sample mouse colitis study were scored in two external human cohorts (87 UC/21 controls and 74 active UC/11 controls), using 12,109 common one-to-one orthologs. Ten primary score comparisons underwent joint Benjamini–Hochberg correction.

Results: Among 7,300,798 eligible FAERS reports, 11,352 included UC. Eight candidates met the specified reporting criteria; seven retained support after UC-indication exclusion. Secukinumab and isotretinoin had 204 and 130 UC reports, with RORs of 4.49 (95% CI 3.90–5.16) and 3.79 (3.19–4.51). Valganciclovir decreased from nine to three reports after exclusion and became imprecise. In human mucosa, experiment-2 IL-17A and IL-17RA blockade signatures scored lower in UC in both cohorts; experiment-1 IL-17RA showed a positive difference in only one cohort. IL-23p19 and IL-12/23p40 blockade signatures scored lower in UC in both cohorts. These patterns persisted across the planned signature-size sensitivity analysis.

Conclusion: Event-centered analysis differentiated reporting associations by their indication context. External experimental and patient data did not support a uniform UC-like transcriptional pattern following IL-17 blockade, refining the mechanistic interpretation of the reporting signals. The findings identify priorities for drug-specific clinical investigation without estimating incidence or establishing causality.

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Cite

BibTeXRIS
BibTeX
@article{long2026ulcerative,
  title = {{Ulcerative colitis reporting across medications: FAERS analysis and cross-species transcriptomic triangulation}},
  author = {Huan Long and Caihua Duan and Jiusi Liu and Nanxi Xiao and Jiang Huang and Huilei Zeng and Zhenling Gao and Yao Chen},
  journal = {Frontiers in Immunology},
  year = {2026},
  month = oct,
  doi = {10.3389/fimmu.2026.1827266},
  url = {https://www.frontiersin.org/articles/10.3389/fimmu.2026.1827266/full},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Ulcerative colitis reporting across medications: FAERS analysis and cross-species transcriptomic triangulation
AU  - Huan Long
AU  - Caihua Duan
AU  - Jiusi Liu
AU  - Nanxi Xiao
AU  - Jiang Huang
AU  - Huilei Zeng
AU  - Zhenling Gao
AU  - Yao Chen
PY  - 2026
DA  - 2026/10/09
JO  - Frontiers in Immunology
DO  - 10.3389/fimmu.2026.1827266
UR  - https://www.frontiersin.org/articles/10.3389/fimmu.2026.1827266/full
AB  - Background: Ulcerative colitis (UC) is reported with medications from different therapeutic classes. We examined these reporting associations together with recorded clinical context and tested whether experimental cytokine-blockade signatures align with human UC mucosal expression.  Methods: FAERS reports from 2004Q1–2024Q4 were restricted to health professionals and primary-suspect medications. Ten previously identified candidates were evaluated using unique report–generic counts, reporting odds ratios (RORs), proportional reporting ratios, and a supportive Bayesian information component. Sensitivity analysis excluded complete reports recording UC as an indication. Directional signatures from five antibody-versus-isotype contrasts in a 42-sample mouse colitis study were scored in two external human cohorts (87 UC/21 controls and 74 active UC/11 controls), using 12,109 common one-to-one orthologs. Ten primary score comparisons underwent joint Benjamini–Hochberg correction.  Results: Among 7,300,798 eligible FAERS reports, 11,352 included UC. Eight candidates met the specified reporting criteria; seven retained support after UC-indication exclusion. Secukinumab and isotretinoin had 204 and 130 UC reports, with RORs of 4.49 (95% CI 3.90–5.16) and 3.79 (3.19–4.51). Valganciclovir decreased from nine to three reports after exclusion and became imprecise. In human mucosa, experiment-2 IL-17A and IL-17RA blockade signatures scored lower in UC in both cohorts; experiment-1 IL-17RA showed a positive difference in only one cohort. IL-23p19 and IL-12/23p40 blockade signatures scored lower in UC in both cohorts. These patterns persisted across the planned signature-size sensitivity analysis.  Conclusion: Event-centered analysis differentiated reporting associations by their indication context. External experimental and patient data did not support a uniform UC-like transcriptional pattern following IL-17 blockade, refining the mechanistic interpretation of the reporting signals. The findings identify priorities for drug-specific clinical investigation without estimating incidence or establishing causality.
SN  - 1664-3224
ER  -